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November 27, 2015

The passing of Dr. Frances Kelsey at 101

Reuel S. Amdur

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The recent passing of Dr. Frances Kelsey at the age of 101 in London Ontario is an occasion for remembering her courage in saving families of having seriously deformed children due to pregnant women taking thalidomide during pregnancy.

Kelsey, a Canadian, began her service in 1960 with the U.S. Food and Drug Administration as a reviewer for drug approvals.  Soon she was asked to look at thalidomide, a drug for pregnant women suffering from morning sickness and insomnia.  She demanded evidence of its safety.  The evidence was not forthcoming, and she dug her heels in.

Thalidomide was approved in Canada and Europe, with tragic consequences.  These consequences became clear in 1961—babies born blind, with defective or missing limbs, and other defects.

Kelsey was just a civil servant with the courage to a corporation that brought as much pressure as it could on her.  She held her ground.  As a result, the impact of the drug on infants in the United States was limited.  The U.S. distributor was able to provide free samples to doctors, resulting in some cases of infant deformity in the United States but the worst consequences were averted.

In addition to protecting the birth of deformed infants, her efforts also helped the Kennedy administration to toughen up the regulations of the Food and Drug Administration.

Canada has had a somewhat parallel situation.  Linda Keen, unlike Kelsey, had a top position in her operation.  She was President and Chief Operating Officer of the Canadian Nuclear Safety Commission.  Also unlike Kelsey, she was far from being a newbie.  She was a career civil servant with some 20 years of service.  However, like Kelsey, she refused to buckle to illegitimate pressure and insisted on adhering to standards to protect the public.

Her baptism of fire came in 2007.  Atomic Energy of Canada Limited had shut down the Chalk River nuclear reactor for routine maintenance.  The reactor was old, passed its replacement date, and the government was loathe to provide the money to develop new facilities.  Keen balked at the situation and ruled that restarting the reactor in the state of the then state of the facility presented an unacceptable level of risk, due to coolant pumps not being connected to a backup energy supply.  Earthquakes occur in the Chalk River area from time to time.

As Chalk River has been the source of medical isotopes, the shutdown was serious both in Canada and elsewhere in the world reliant on the isotopes.  So even while she and the Commission found that the risk was unacceptably high, Parliament decided that because of the need for the isotopes it was necessary nonetheless to restart the reactor.  Beginning in November 2007, it was restarted on December 16 of that year.

Chalk River has not been immune to problems with the reactor.  It had nuclear accidents in 1952 and 1958.  On December 5, 2008, the reactor was shut down again till December 11, due to a leakage of heavy water.  Then the same problem, worse this time, led to a shut down from May 2009 to August 2010, causing a major isotope shortage.

The Harper government’s approach has been to privatize the mess, with substantial subsidization from the taxpayer.  It wants the problem out of the government’s hands and out of responsibility.

So let’s get back to Kelsey and Keen.  Kelsey, this newbie in the U.S. Food and Drug Administration, has been recognized and honored.  Hired in 1960, on August 8, 1962, President John F. Kennedy personally presented her with the Distinguished Federal Civil Service Medal.  As noted, her brave stand led to tighter drug approval regulations.

And Keen?  She was castigated by Prime Minster Harper.  Gary Lunn, then Minister of Natural Resources, told her that the government had lost confidence I her and forced her removal.

In 2008, she appeared before the Natural Resources Committee of Parliament.  On that occasion, Liberal MP Omar Alghabara told her, “For no other reason, from what I can see, than purely political reasons, unfortunately your name and reputation have been dragged through the mud by this Prime Minister.”

Keen was made a scapegoat for the government’s failure to maintain and replace the Chalk River reactor and to maintain an adequate production of medical isotopes.  Various workarounds are in place and a new facility is planned in the Netherlands.

Frances Kelsey has been showered with praise and awards, including being names to the Order of Canada.  Keen has been smeared by her own government, by Minister Lunn in particular.  She performed her services to Canada faithfully and honorably, refusing to abandon her duty in the face of Harper’s pressure and denunciations.  But even after leaving her post she continues to promote the public interest.

Gary Lunn was MP for Saanich-Gulf Islands in British Columbia.  In the 2011 electoral campaign, Linda Keen gave her support to Green Party leader Elizabeth May, who went on to defeat Lunn.  Keen provided a public service by refusing to back down on her conclusion about the safety risk at Chalk River.  She performed another in helping to retire a particularly nasty Member of Parliament.

Will a new government give her the recognition to which she is surely entitled?  Canada made Kelsey a member of the Order of Canada.  Why not Keen?

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